Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/02—Holding devices, e.g. on the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B46/00—Surgical drapes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B46/00—Surgical drapes
  • A61B46/20—Surgical drapes specially adapted for patients
  • A61B46/23—Surgical drapes specially adapted for patients with means to retain or hold surgical implements
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B46/00—Surgical drapes
  • A61B46/20—Surgical drapes specially adapted for patients
  • A61B46/27—Surgical drapes specially adapted for patients tubular, e.g. for arms or legs
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B46/00—Surgical drapes
  • A61B46/20—Surgical drapes specially adapted for patients
  • A61B2046/205—Adhesive drapes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B46/00—Surgical drapes
  • A61B46/20—Surgical drapes specially adapted for patients
  • A61B46/23—Surgical drapes specially adapted for patients with means to retain or hold surgical implements
  • A61B2046/234—Surgical drapes specially adapted for patients with means to retain or hold surgical implements with means for retaining a catheter
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B46/00—Surgical drapes
  • A61B46/20—Surgical drapes specially adapted for patients
  • A61B46/23—Surgical drapes specially adapted for patients with means to retain or hold surgical implements
  • A61B2046/236—Surgical drapes specially adapted for patients with means to retain or hold surgical implements with means for collecting drain fluid, e.g. drain tubes

Definitions

• a surgical instrument placement tool for holding tools for angiographic procedures
• the present invention relates to a surgical instrument placement tool for holding tools for angiographic procedures in the fields of invasive radiology, vascular surgery and cardiology.
• It also relates to a tool holder for holding tools for angiographic procedures in the fields of invasive radiology, vascular surgery and cardiology in case a surgical team operates at a table of extra length.
• the endovascular instruments are mainly introducers, catheters, spring guide wires, stents and balloons. There are many types of tools in different length and diameter from several centimetres to 3 meters in length. In the majority of procedures, at least 7-8 tools are used and in many others 10-20 tools and more.
• the Seldinger technique is a medical procedure often used. It is named after Dr. Sven-Ivar Seldinger, a Swedish radiologist, who introduced the procedure in 1953.
• the desired vessel or cavity is punctured with a sharp hollow needle called a trocar, with ultrasound guidance if necessary.
• a round-tipped spring guide wire is then advanced through the lumen of the trocar, and the trocar is withdrawn.
• a blunt dilator can now be passed over the guide wire into the cavity or vessel.
• the tip of a catheter is threaded into the vessel using the spring guide wire.
• the spring guide wire is withdrawn.
• the endovascular tools are sterile and due to their flexibility and length it is a problem to hold them in one place without making them non-sterile ("they have their own life"). They fall or become non- sterile often. They are hard to handle by one person and hold in an appropriate way. Their cost is very high and a loss of such tools in a procedure has economic implications. Due to their flexibility and length, the operator needs more assistants and it is sometime challenging to handle the tools. Often two to three persons are needed to hold a long catheter/wire.
• US 4,476,860 discloses surgical drapes having a plurality of pockets facing one another for retaining surgical instruments.
• US 5,010,899 discloses a surgical drape have a plurality of loops for maintaining medical devices during the procedure.
• US 5,464,025 discloses a self- contained surgical tubing management system where all of the required surgical hand pieces and power and fluid tubing, cables and connections are incorporated in a single disposable package. The system includes a sterile sheet that covers at least a portion of the patient's body, and has pockets and fasteners that contain and position the instruments, so that they are easily accessible during the operation process. None of these meet existing needs in a satisfactory manner.
• the main object of the present invention is to provide a surgical instrument placement tool for holding tools for angiographic procedures in the fields of invasive radiology, vascular surgery and cardiology. That object is achieved in accordance with the present invention in that the placement tool comprises:
• a surgical drape for covering a patient of average size from at least the groin down to the region of the feet of the patient when the patient is lying with spread legs;
• a horizontal pouch member attached to a foot end of the surgical drape at a location horizontally to a lower portion of the spread legs of the patient, said pouch member having a vertical double curvature bottom surface and an open side facing vertically upward; and preferably
• the pouch member may project horizontally beyond the feet of the lying average sized patient.
• a suitable size of the projection of the pouch member is on the order of half a meter, and then the double curvature bottom surface has a horizontal diameter on the order of half a meter.
• an arcuate member is located in the pouch member for maintaining the shape of the double curvature bottom surface.
• the arcuate member suitably has two end portions extending horizontally between the spread legs of the lying average size patient, and the surgical drape has two pockets for receiving and holding at least the very ends of said end portions.
• the tool holders suitably are substantially comb-shaped but have comb teeth that are thicker at their tips than at their roots, so that the space between the teeth is smaller at the tips than at the roots.
• the tool holders preferably are made of rubber or similar elastic material. As the teeth tips on both sides of the space will be pressed away from each other on insertion of the long springy instruments and other surgical tools in the tool holders, it will be easy to mount the instruments in the tool holders and they will be retained therein. A single-hand grip is sufficient for inserting them into the tool holder and removing them there from. Since in a majority of procedures at least 7-8 tools are used, the number of spaces between the comb teeth suitably is on the order often.
• At least some of the spaces between the teeth of the tool holders may be color coded.
• the tool holders are attached to the surgical drape by tape having adhesive on both sides.
• the upwardly exposed interior surface of the surgical drape may be marked with recommended locations for attaching the tool holders so as to facilitate the attachment at optimum locations.
• the surgical drape has an opposed upper end, and to fix the placement tool to the patient, the upper end has one side of a piece of tape having adhesive on both sides adhered thereto, the other side carrying a removable protective film for adhering the placement tool to the patient.
• the length of the tape at the upper end of the surgical drape may be sufficient to extend a width across the patient of 30-50 cm (12- 20 in.). If desired, the upper end of the surgical drape may have a wing extending toward a nave of the patient.
• the surgical drape is made from a laminate having a middle layer of plastic film covered by fibrous surface layers.
• the pouch member should be soft, tight and strong and is made from a laminate having a middle layer of plastic film covered by fibrous surface layers.
• the plastic film preferably is reinforced by embedded fibers to facilitate the maintaining of the shape of the pouch member.
• one or more stiffening members may be provided in or bonded to the laminate pouch member to assist in maintaining its desired shape. With plastics in the pouch member, it can be attached to the surgical drape be welding.
• Another object of the present invention is to provide tool holder for holding tools for angiographic procedures in the fields of invasive radiology, vascular surgery and cardiology in case a surgical team operates at a table of extra length.
• the tool holder is substantially comb-shaped but has comb teeth that are thicker at their tips than at their roots, so that the space between the teeth is smaller at the tips than at the roots, and that the tool holder has a back side having one side of a piece of tape having adhesive on both sides adhered thereto, the other side carrying a removable protective film for adhering the tool holder to any useful surface, such as an ordinary sterile drape.
• the tool holder preferably is made of an elastic material, the number of spaces between the comb teeth is on the order often, and suitably at least some of the spaces between the teeth of the tool holders are color coded. If the tool holders are acquired separately and not as included in the surgical instrument placement tool of the invention, a pack containing four tool holders appears to satisfy most requirements. Four tool holders can easily be positioned so as to permit the long springy instruments to form a loop, in which they are movable in their longitudinal direction but yet maintained comparatively safe in the tool holders.
• FIG. 1 is a schematic perspective view of a preferred embodiment of the surgical instrument placement tool of the present invention positioned on a patient lying on a surgical table, an endovascular instrument being held in the placement tool.
• Fig. 2 is a schematic perspective view of a horizontal pouch member included in the
• FIG. 3 is a schematic perspective view of a generally comb-shaped tool holder included in the placement tool of Fig. 1 and having a spring guide wire passing through a space between two teeth.
• Fig. 4 is a schematic plan view of a lower portion of a patient lying on a surgical table and having the surgical instrument placement tool of Fig. 1 covering his legs and the lower part of his abdomen.
• Fig. 1 is a schematic perspective view of a preferred embodiment of the surgical instrument placement tool 1 of the present invention positioned on a patient 2 lying on his back with spread straight legs on a surgical table 3. Although the upper portion of the patient is shown uncovered, it would in real life normally be essentially covered by sterile drapes in accordance with general hospital practice.
• An endovascular instrument 4 is shown held in the placement tool 1, e.g. to be and is introduced percutaneously or through the skin, into a large blood vessel of the patient 2.
• the blood vessel chosen is the femoral artery or vein found near the groin. Access to the femoral artery for example, is required for coronary, carotid, and cerebral angiographic procedures.
• the instrument 4 When the instrument 4 is a catheter, it can be used for inserting an intravascular balloon, stent or coil. Stents and coils are composed of fine wire materials such as platinum and can be expanded into a predetermined shape once they are guided into place. Of course, even though the shown instrument is an endovascular one, the present invention is useful for holding also other tools for angiographic procedures in the fields of invasive radiology, vascular surgery and cardiology.
• the placement tool 1 comprises:
• a pouch member 20 having a generally horizontal, upwardly exposed, bottom surface 27, which pouch member 20 is attached to a foot end 12 of the surgical drape 10 to extend to a lower portion of the spread legs of the patient 2, said pouch member 20 having a vertical wall portion 28 providing a double curvature bottom surface 21 and an edge 22 that provides for exposing a portion of said upwardly exposed bottom surface 27 of the pouch member 20; and preferably
• the pouch member 20 projects horizontally beyond the feet of the lying average size patient 2 a distance, which generally is on the order of half a meter (preferably in the range of 03-0,8 m), and the double curvature bottom surface 21 has a horizontal diameter (i.e. two times r 1; see fig 4) that generally is of about the same length.
• the pouch 20 may be produced as a separate unit that is attached to the drape 10 in any appropriate manner, e.g. gluing and/or welding (plastic).
• the wall member 28 presenting a vertical double curvature bottom surface 21 the sometimes very long and springy surgical instruments are hindered from escaping out away from the working space, i.e. the space surrounded by the leg portions 17 of the drape 10 and the wall 28 of the pouch. This will free some hands (nurse/assistant) and will avoid the falling of a tool or its becoming non-sterile.
• the walls 17 ',28 may preferably be arranged such that they totally surround the placement areas 13,27, whereby liquids are hindered from escaping.
• the double curvature bottom surface 21 has a first curvature with a relatively large radius ri, that forms a U- shape of the inner surface 21 of the wall 28 (and since all parts of the wall 28 have substantially the same thickness also the outer periphery is U-shaped, as seen from above in fig. 4), to allow a smooth continuous bend long springy instruments. Further it has a second curvature with a relatively small radius r 2 , along the inner surface 21 in a transversal direction, that also present a U-shape (and an outer U-shaped periphery) seen from the side (see fig 2) to retain the long, springy instruments within the channel that is formed by the cross sectional design of the inner surface 21 of the wall 28.
• r 2 preferably is within the range 20- 100 mm, but it is evident for the skilled person that a big variety of cross sectional shapes of the surface may be used, to obtain the desired retaining function, i.e. a shape that deviates from a smooth U-shape, e.g. in an extreme embodiment having a U with rectangular corners.
• an arcuate member 23 is shown located in the pouch member 20 for maintaining the shape of the double curvature bottom surface 21 at least in a generally horizontal plane.
• the arcuate member 23 may be of any suitable shape and material, e.g. a plastic bar or tube.
• the arcuate member 23 has two end portions 24, 24' extending horizontally between the spread legs of the lying average size patient 2. At least the very ends of said end portions 24, 24' are received and held in e.g. two pockets 14, 14' provided on the surgical drape 10. In the embodiment of Fig. 4, these pockets are situated generally on level with and close to and between the thickest portions of the calves of the spread legs of the lying average size patient 2 i.e.
• FIG. 4 designates a possible location for the introduction of the endo vascular instrument 4 into a large blood vessel such as the femoral artery or vein of the patient 2.
• a large blood vessel such as the femoral artery or vein of the patient 2.
• four tool holders 30-31 ' are used but, if desired, it is possible to use a larger or smaller number of tool holders.
• the four tool holders 30-31 ' shown are attached to the surgical drape 10 with a first pair 30, 30' forming a straight line just inside of the pockets 14, 14', and the tool holders of the second pair 31, 31 ' are located spaced from each other and forming a parallel line just inside the foot end of the surgical table 3, where the pouch member 20 is attached to the surgical drape 10.
• the four tool holders 30-31 ' may be attached to the surgical drape 10 at other locations, if desired.
• the tool holders 30-31 ' are substantially comb-shaped but have comb teeth 32 that are thicker at their tips 33 than at their roots 34, so that the space 35 between the teeth 32 is smaller at the tips 33 than at the roots 34.
• the long springy instruments 4 and other surgical tools can be safely held without being preventing from moving in their longitudinal direction.
• the tool holders 30-31 ' preferably are made of rubber or similar elastic material, more preferred of a porous kind which will decrease weight and cost. As the tooth tips 33 on both sides of the space 35 will be pressed away from each other on insertion of the long springy instruments 4 and other surgical tools in the tool holders 30-31 ', it will be easy to mount the instruments 4 in the tool holders 30-31 ' and they will be retained therein. A single-hand grip is sufficient for inserting them into the tool holder 30-31 ' and removing them there from.
• At least some of the spaces 35 between the teeth of the tool holders 30-31 ' may be color coded (not shown).
• the tool holders 30-31 ' are attached to the surgical drape 10 by tape (not shown) having adhesive on both sides, but if desired it is, of course, possible to use some other attachment method.
• the upwardly exposed interior surface of the surgical drape 4 may be marked with recommended locations for attaching the tool holders 30-31 ' so as to facilitate the attachment at optimum locations.
• the optimum locations are not shown separately, but in most cases, the positions shown in Figs. 1 and 4 are optimum locations.
• the surgical drape 10 has an opposed upper end 11.
• the upper end 11 has one side of a piece of tape 15 having adhesive on both sides adhered thereto, the other side carrying a removable protective film, not shown, for adhering the placement tool 1 to the patient 2 after removal of the protective film
• the length of the tape 15 at the upper end 15 of the surgical drape 10 may be sufficient to extend a width across the patient of SO- SO cm (12-20 in.).
• the upper end 11 of the surgical drape 10 may have a wing 16 extending toward a nave of the patient 2.
• the wing 16 may carry an instruction (not shown), if desired, as to direction when preparing the patient on the surgical table for surgery.
• the surgical drape 10 preferably is made from a flexible laminate e.g. of a kind that is known per se and used already as surgical drapes, having a middle layer of plastic film covered by fibrous surface layers.
• the film may be a liquid- impermeable polyethylene film
• the top fibrous surface layer may be of a liquid- absorbent nonwoven material
• the bottom fibrous surface layer facing the patient 2 may be of cellulose wadding or the like to enhance patient comfort by absorbing perspiration and preventing direct contact of the patient's skin with the plastic film.
• many other combinations of layers and materials therein are possible.
• the pouch member 20 should be soft, tight and strong and is made from a flexible laminate.
• the laminate used here will not come into contact with the patient's skin, so the bottom layer of cellulose wadding or the like may not be needed.
• the laminate used in the pouch member 20 may have a bottom layer of plastic film covered by a fibrous surface layer.
• the film may be a liquid- impermeable polyethylene film, and the top fibrous surface layer may be of a liquid-absorbent nonwoven material or a woven fabric.
• the laminate e.g.
• one or more stiffening members 26 may be provided in or bonded to the laminate pouch member 20 to assist in maintaining its desired shape.
• the desired shape may be created by punching and gluing of the laminate (preferably having some resiliency) to form the desired shape and strength.
• the generally vertical bottom of pouch member 20 is provided with a plurality of generally vertical stiffening members 26.
• the stiffening members 26 may be located on the exterior plastic film side or on the interior fibrous surface layer side of the pouch member bottom or on both sides. As an example, they may be provided by laying parallel runs of a hardening or solidifying plastic material on the pouch member bottom and maintaining the shape of the bottom until the plastic material has hardened or solidified, preferably thereafter providing a resiliency such that the drape/pouch 10/20 may be kept flat in its packaging and automatically expand to its intended shape when unpacked. If desired, it is of course also possible to lay two or more parallel runs (not shown) crossing each other to create a net structure of stiffening members. Alternatively, a preformed net-shaped stiffening member (not shown) may be attached to the pouch member 20. For the skilled person within the polymeric field it is evident that there exist a large variety of suitable plastic materials for making the parallel runs/stiffening members 26.
• the stiffening members 26 may be shaped, in an embodiment not shown, to provide attachment points, for the arcuate member 23.
• attachment points may be formed as simple shallow recesses or as more complicated snap connections.
• the arcuate member 23 and stiffening members are integrated to form a unit which may provide the desired shape of flexible drapes 10 and pouches 20, upon introduction thereof.
• a preferred laminate for the pouch member 20 is a traditional kind for surgical drapes. However, to provide the desired functionality, inter alia sufficient strength and flexibility, many other combinations of layers and materials therein are possible.
• the plastic film in the pouch member 20 may be useful not only for tightness purposes but makes it possible to attach the pouch member 20 to the surgical drape 10 by welding.
• the invention is not limited to what has been described above but maybe be varied within the scope of the appended claims.
• the main function of the invention i.e. the ability to hinder catheters and other long instruments to fall out/on to the floor, is obtained also without any tool holders positioned on to the drape and/or pouch.
• the material of the drape and/or pouch may vary within wide frames to fulfill the desired basic functionality and that different properties may be achieved by alternate laminate/s and/or the manner of combining laminates and/or the manner of gluing the laminates and/or the manner of attaching support members, etc.
• gluing of layers on to each other and by varying the mounting glue and the amount of layers that are glued to each other, varying properties may be achieved, e.g. to adapt to different needs for different kind of applications.
• the tool holders may be made in a big variety of different materials, e.g. depending on need and/or desires and/or different standards, and/or different requirements regarding different possible aspects.
• one aspect that, at least in some parts of the world, is getting more and more of attention is the environmental aspect.
• the invention is to use materials that are biologically decomposable, as are many fiber products and indeed also polymers of today.
• all of the parts of the invention should be disposable and in such a case it would of course be an advantage to also have all parts produced in such environmental friendly materials.
• many other means may be used than the above described support device 23, e.g.

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• Health & Medical Sciences (AREA)
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• Animal Behavior & Ethology (AREA)
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• 2010
  • 2010-08-19 US US13/391,691 patent/US20120227751A1/en not_active Abandoned
  • 2010-08-19 JP JP2012526687A patent/JP5706422B2/ja active Active
  • 2010-08-19 WO PCT/SE2010/050896 patent/WO2011025439A1/en active Application Filing
  • 2010-08-19 AU AU2010287024A patent/AU2010287024B2/en active Active
  • 2010-08-19 EP EP10812398.5A patent/EP2470107B1/de active Active

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